Investigating a new imaging tracer for diagnosing giant cell arteritis
Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
PHASE2 · Insel Gruppe AG, University Hospital Bern · NCT06335888
This study is testing a new imaging method called AzaFol-PET/CT to see if it can better diagnose giant cell arteritis in people aged 50 and older compared to the current standard method.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Bern) |
| Trial ID | NCT06335888 on ClinicalTrials.gov |
What this trial studies
This open-label clinical trial aims to evaluate the efficacy of AzaFol-PET/CT imaging in diagnosing giant cell arteritis (GCA) compared to the standard 2-[18F]FDG-PET/CT. The study will assess the safety and tolerability of AzaFol in patients with suspected GCA. Participants aged 50 and older will undergo imaging at a single timepoint to determine the tracer's ability to distinguish between vasculitic and atherosclerotic lesions. The hypothesis is that AzaFol, which targets activated macrophages, will provide more accurate diagnostic information than the current standard.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with clinical suspicion of giant cell arteritis.
Not a fit: Patients with folate deficiency or those on medications that significantly impair folic acid levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of giant cell arteritis, improving patient outcomes and treatment strategies.
How similar studies have performed: While the use of AzaFol is a novel approach, similar studies using targeted tracers have shown promise in improving diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals ≥ 50 years with clinical suspicion of GCA * Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit * Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. * Are willing and able to comply with procedures required in this protocol. Exclusion Criteria: 1. Folate deficiency 2. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug 3. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed) 4. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\[18F\]FDG tracer application 5. Glucose level \> 10 mmol/l at the timepoint of 2-\[18F\]FDG PET/CT 6. Unable to remain in the PET/CT for the duration of the examination 7. Unable to lie still for the duration of the examination (45 min) 8. Unable not to eat or drink (except water) for 6 hours prior to 2-\[18F\]FDG tracer application 9. Prior PET-imaging within 60 days before baseline 10. Intake of vitamin supplements containing \> 1mg/day folic acid within 48 h prior to the PET/CT with AzaFol 11. Known hypersensitivity or allergy to folic acid 12. Enrolment of the investigator, his/her family members, employees and other dependent persons 13. Participation in another study with investigational drug within the 7 days preceding and during the present study.
Where this trial is running
Bern
- Department of Rheumatology and Immunology, University Hospital Bern, Inselspital — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Britta Maurer — Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
- Study coordinator: Britta Maurer
- Email: RI-Studien@insel.ch
- Phone: +41 31 63 2 7229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Giant Cell Arteritis, Tracer, PET imaging